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England’s NICE Unconvinced That Sanofi’s Sarclisa Is Cost Effective After Cancer Drugs Fund Review

 
• By Eliza Slawther

Sanofi says it will engage further with NICE after the health technology assessment body rejected Sarclisa for previously-treated multiple myeloma, and that it is “hopeful a way forward can be found.”

Medical Balance Equality
• Source: Shutterstock

Sanofi has hit another bump in the road to reimbursement for its multiple myeloma therapy Sarclisa (isatuximab) after NICE, the health technology assessment (HTA) body for England and Wales, said the drug was not cost effective when used in combination with pomalidomide and dexamethasone (pom-dex) for relapsed and refractory multiple myeloma (RRMM).

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More from Europe

Leqembi Launch Set For Germany & Austria, EU-Wide Staggered Release Planned

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

More from Geography

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.